Brief description of study

Non-randomized multicenter post-market study to confirm the long-term safety and
effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage
stent system for revascularization of de novo stenotic lesions in the superficial femoral
artery in 100 compliant patients suitable for stent angioplasty.
The CE-approved device will be used according to its intended use. Beyond the standard of
care no further interventions are scheduled. Therefore, this trial is subject to the
exception to the rule §23b of the German Medical Device Act (MPG), which includes the
national implementation of EC directive 93/42/EEC.

Detailed Study Description

The aim of this non-randomized post-market clinical follow-up study is to confirm long-term
safety and effectiveness of the CE-approved Camouflage-coated self expandable RESISTANT
Camouflage stent system for revascularization of de novo stenotic lesions in superficial
femoral artery in 120 compliant patients suitable for stent angioplasty. The primary end
point is the target lesion revascularization after 12 months. Further follow-ups are
scheduled at discharge, 30 days, 6 and 24 months.